How the Safe~Seal™ Works
Directions and Packaging Insert
Frequently Asked Questions:
1. What makes this endotracheal tube better?
3. Do I need to worry about the tube kinking?
4. What about sterilization and cleaning?
6. Will water or fluids leak past the tube during procedures dentals?
7. How does the tube prevent over pressurization of the lungs patient?
8. What about “dead air space’ in small, brachiocephalic breeds?
9. Who has been using this tube?
10. How do I determine the correct size of tube to use?
11. Why do I hear air leakage sometimes when I first insert the Tube?
12. What is the proper method of inserting the tube?
13. Can positive pressure be applied?
14. Why does the Safe~Seal tube cause no threat of damage to the Trachea?
15. Sterilization recommendations
16. I feel that there is too much pressure to insert the tube. Is this a problem?
17. What if we see see blood when we remove the Tube?
18. Why is it hard to remove the stylet while the Tube is in the patient?
How the Safe~Seal™ Works
Almost all ET tubes used today depend upon an inflation cuff to seal the tube in the trachea, except the Safe-Seal™ ET tube featuring the Blaine Bafflex System. This new technology uses a series of 6 silicone baffles with carefully engineered pattern and spacing to seal the trachea without pressure points.
The flexible baffles allow an “o-ring effect”. The Safe-Seal ET tube lies in the trachea and the sealing baffles touch the tracheal wall leaning towards the larynx. Thus, when the patient inspires the silicone baffles are sucked against the trachea forming a tight seal.
The special design allows passage of pressure exceeding 20-30 centimeters of water in the patient’s lungs. If the pop-off valve is accidentally left closed, the excess pressure is released and no harm will come to the patient. If more than 20-30 centimeters of water pressure is desired, the tube is merely withdrawn ½ inch causing the baffles to flip over and the tip will then face caudally thereby allowing as much pressure to be applied as deemed necessary.
These soft, flexible baffles are atraumatic to the tracheal surface due to the limited contact of the baffles.
There is minimal contact with the tracheal wall when using the Safe-Seal tube as opposed to the large area of contact of inflation cuff tubes. This means the tube can be left in the same position for extended periods of time.
Another advantage is the “squeegee” effect when extubating, by scraping the trachea clean of any fluids present. The Safe-Seal ET tube with the Blaine Bafflex System eliminates dangers of deflation or over inflation.
The standard tubes used today are constructed of rigid, curved plastic. This shape and rigidity
forces the tip of the tube against the tracheal wall when inflated, causing a point of pressure.
The Safe-Seal tube’s baffles keep the tip of the
tube centered in the trachea. It is ultimately safer to use and can cause no damage to the trachea.
Frequently Ask Questions:
1. What makes this endotracheal tube better?
The Safe-Seal tube was developed to eliminate the problems associated with inflation cuff tubes. No danger of leakage, over pressurization, under inflation or need for replacement make this tube safer and cost effective. It cleanses the trachea upon extubation and is atraumatic to the tracheal mucosa.
2. How long will it last?
The Safe-Seal has been used in clinical situations for over seven years failure or need for replacement. The solid one-piece silicone design will last for years.
3. Do I need to worry about the tube kinking?
The soft, flexible nature of the tube is an extreme advantage. Rotation of the patient will not cause harm to the trachea because the baffles rotate easily. As with all tubes, a right angle bending force could cause kinking. The operator should be aware that the tube should be securely attached to the snout and if using a non-rebreather apparatus, that it should be kept in front of the patient on the table. Kinking has not been a problem in the seven year clinical trials. When using the smallest tube, the tip of the tube is ¼ inch and is therefore more flexible. The shaft of the tube is 3/8 inch diameter and resistant to kinking. As long as the flexible tip is safely inside the trachea, it is not subjected to bending forces.
4. What about sterilization and cleaning?
The medical grade silicone is autoclavable and resistant to cold disinfectants. Gas sterilization is safe but not necessary. The durable silicone can be scrubbed in the usual fashion.
5. How many tubes do I need?
Only 4 sizes of tubes are necessary for a small animal practitioner for dogs weighing 10 to 200 pounds. This makes the Safe-Seal Endotracheal tube very cost effective. It’s durability gives this tube many years of use.
6. Will water or fluids leak past the tube during procedures such as dentals?
No. The tube is designed to seal with 20-30 centimeters of water pressure in the trachea. Unless positive pressure exceeding this amount is applied in the pharynx, no passage of fluid is allowed to enter the lungs.
7. How does the tube prevent over pressurization of the lungs of my patient?
The carefully spaced and tapered baffles are designed to allow excess of 20-30 centimeters of water to bypass and escape. Thus, if the pop-off valve is accidentally left closed, the pressure will be released and no harm will come to the patient.
8. What about “dead air space” in small, brachiocephalic breeds?
The tidal volume of a dog’s lungs determines if dead air space is a problem. A 20 pound pug with a short nose has roughly the same tidal volume as a 20 pound Whippet with a long nose. The length of the nose is irrelevant. Use of a non-rebreather for small dogs is useful whether using the Safe-Seal tube or the conventional inflation cuff tubes.
9. Who has been using the tube?
Many veterinarians have participated in our trials, including board certified doctors. Some of their testimonials are included in this web site. The response has been overwhelmingly positive. Check them out!
10. How do I determine the correct size of tube to use?
There is tremendous variation in the size of the trachea and larynx between different breeds of dogs. As a general guide line the small tube will properly fit dogs ranging from 10 to 30 pounds. The middle size tube will usually work in dogs from 25 and up to 80 pounds and the large tube will work well in dogs from 70 to 200 pounds. A simple rule of thumb is if the tube feels too tight or too loose upon insertion, use the next size tube, smaller or larger as appropriate.
11. Why do I hear air leakage sometimes when i first insert the Tube?
If a patient is “light” when first intubated, he may cough or forcefully expire. The baffles will release pressure exceeding 20-30 centimeters of water. So when first tubed, a “honking” sound of this pressure release is normal. When the patient is breathing normally, no leakage will occur. In either case, there will be no leakage during inspiration, so the patient will be receiving all the oxygen and anesthetic he requires.
12. What is the propert method of inserting the Tube?
The stylet included with the tubes is necessary due to the flexibility of the tube. Insert the tube in the usual fashion and stop inserting while the tube is in a forward motion. This will insure the baffles will seal the trachea and allow excess pressure to escape. Remove the stylet and secure the tube to the snout in the usual ways.
13. Can positive pressure be applied?
Yes, 20-30 centimeters of pressure can be applied. If the operator desires more pressure, the tube is merely withdrawn ½ inch, and the baffles will flip over and as much pressure as deemed necessary is available.
14. Why does the Tube cause no threat of damage to the trachea?
There is minimal contact with the tracheal mucosa with the Safe-Seal ET tube and the
pressure caused by the bending of the baffles varies between 1-3 centimeter of water. Inflation cuff tubes have a large area of tracheal contact and require up to 30 centimeters of water pressure to seal. If inadvertent movement of the tube occurs, the tube will rotate and not cause friction damage to the mucosa. The baffles keep the tip of the ET tube centered in the trachea at all times, thus not allowing pressure points typical of inflation cuff tubes.
15. Sterilization Recommendations:
Method: Steam sterilize the product using the following parameters after removing all non-autoclavable protective packaging and labeling:
Cycle: High Vacuum, Temperature 270 F (132 C), 4 minutes of exposure
Cycle: Gravity, Temperature 270 F (132 C), 10 minutes of exposure
Cycle: Vacuum, Temperature 270 F (132 C), 10 minutes of exposure
16. “I feel that I have to use too much pressure to insert the Tube. Is this a problem?
No. After over 6000 procedures performed in trials, no problems have arisen to suggest that this is a problem. The pressure you feel while inserting the tube is created by the bending of the baffles at the level of the arytenoid cartilages which are very tough. The needed pressure of the baffles (Blaines) is about 3 centimeters of water. An inflated cuff on traditional tubes exerts 20-30 centimeters of water – which is about 10 times the additional pressure in a more sensitive area then the passage of the Blaines through the arytenoids. The amount of pressure or resistance that you feel is similar to the pressure you eel when passing a large stomach tube down the esophagus. Lubrication of the baffles either with water or KY is beneficial in reducing the friction at the arytenoids.
17. What if we see some blood when we remove the Tube?
During the first 3 years of our clinical trials on real patients, if blood was noticed on the Tube the source was investigated. In most cases the blood came from the oral cavity from procedures such as dentals. All of the other cases the dogs were scoped and found pathology such as inflammed glottis or larynx caused by coughing, barking, viruses, etc. Remember that any blood or fluid in the throat is removed by the Safe-Seal Tube and is therefore visualized. With inflation cuff Tubes, the blood remains in the trachea and is not seen.
18. Why is it hard to remove the stylet while the Safe~Seal Tube is inserted in the patient?
The head and the neck of the dog needs to be straight in alignment. Align the nose straight to the thoracic inlet, then remove the stylet from the Tube.
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